Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.

AI/ML Overview

This document describes a 510(k) premarket notification for a device called "Coating Material," which is a light-cured, transparent resin sealant for acrylic denture bases. The submission aims to demonstrate substantial equivalence to a predicate device, Heraeus Kulzer, Inc., Palaseal® (K892452).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO 7405/10993)	Reported Device Performance (Coating Material)
Biocompatibility:
Cytotoxicity (ISO 10993-5)	Non-cytotoxic; all test method acceptance criteria met.
Skin Sensitization (ISO 10993-10)	No sensitization under experimental conditions.
Intracutaneous Reactivity (ISO 10993-10)	No signs of irritation; met requirements; classified as not irritant.
Subchronic Toxicity (ISO 10993-11)	No significant systemic toxicity under experimental conditions.
Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) (ISO 10993-3)	Non-clastogenic under experimental conditions.
Genotoxicity (Bacterial Reverse Mutation (AMES) Test) (ISO 10993-3)	Non-mutagenic (non-genotoxic and non-clastogenic) under experimental conditions.
Performance Bench Testing:
Coating applicability (implied from predicate comparison)	Confirmed to conform to required specifications and suitable for intended use.
Properties of the coated surface (implied from predicate comparison)	Smooth, high gloss surface with no evidence of cracking or peeling after being light-cured.
Risk Management (ISO 14971):	Outcomes considered acceptable; all potential risks mitigated.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the sample sizes for the individual biocompatibility tests or performance bench tests. It refers to "extending testing" and "experimental conditions."
Data Provenance: The studies are described as "Non-Clinical Performance Data." The sponsor is Sun Medical Co., Ltd. in Japan, suggesting the studies were likely conducted or overseen in Japan, but this is not explicitly stated for each test. The studies appear to be prospective as they were conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For non-clinical lab tests like biocompatibility and bench testing, "ground truth" is typically established by adhering to standardized test protocols (e.g., ISO standards) and comparing results against predefined acceptance criteria outlined in those standards. The expertise would lie in the accredited laboratories and personnel performing these specific tests rather than a panel of clinical experts establishing a ground truth in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable in the context of these non-clinical, objective laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data where consensus among multiple reviewers is needed to establish a "ground truth" for a diagnosis or specific outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The "Coating Material" is a physical medical device (a resin sealant for dentures), not a software algorithm or AI-based device. Performance testing was conducted directly on the material itself.

7. The Type of Ground Truth Used

For the biocompatibility tests and performance bench tests, the "ground truth" used was adherence to established international standards and their predefined acceptance criteria. For example, for cytotoxicity, the ground truth for "non-cytotoxic" is defined by the criteria within ISO 10993-5. For physical properties like gloss and cracking, the "ground truth" is based on visual assessment against predefined quality metrics.

Biocompatibility: Ground truth established by compliance with ISO 7405, ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11 test methodologies and their respective acceptance limits.
Performance Bench Testing: Ground truth established by adherence to "required specifications" (which would be internal to the manufacturer, but validated against intended use) and visual/tactile assessment of "smooth, high gloss surface with no evidence of cracking or peeling."

8. The Sample Size for the Training Set

This question is not applicable. As stated previously, this is a physical medical device, not an AI or software device that uses training sets.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Sun Medical Co., Ltd. c/o Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K150511

Trade/Device Name: Coating Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: February 26, 2015 Received: February 27, 2015

Dear Ms. Hetrick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150511

Device Name Coating Material

Indications for Use (Describe)

Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

for

Coating Material

1. Submission Sponsor

Sun Medical Co., Ltd. 571-2, Furutaka-cho Moriyama, Shiga 524-0044 Japan Phone: 81-77-582-9978 Fax: 81-77-582-9984 Contact: Mr. Yukihito Yukimune, Pharmaceutical Affairs Department Director

2. Submission Correspondent

Emergo 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 833.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

May 19, 2015

4. Device Identification

Trade/Proprietary Name:	Coating Material
Common/Usual Name:	Coating Material
Classification Name:	Denture Relining, Repairing, or Rebasing Resin
Classification Regulation:	21 CFR § 872.3760
Product Code:	EBI
Device Class:	Class II
Classification Panel:	Dental

5. Legally Marketed Predicate Device(s)

Heraeus Kulzer, Inc., Palaseal® - K892452

6. Device Description

Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface

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provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.

7. Indication for Use Statement

Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture.

8. Substantial Equivalence Discussion

The following table compares the Coating Material to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Sun Medical Co., Ltd.	Heraeus Kulzer, Inc.	Significant Differences
Trade Name	Coating Material	Palaseal®
510(k) Number	K150511	K892452	Not applicable
Product Code	EBI	EBI	Same
RegulationNumber	21 CFR § 872.3760	21 CFR § 872.3760	Same
RegulationName	Denture Base Resin	Denture Base Resin	Same
DeviceDescription	Coating Material is a light-cured denture basecoating that is composedof two liquids that aremixed prior to use, andthen photo-polymerizedby a UV radiation.	Palaseal® is a light-curing,transparent sealing resinthat bonds to any denturematerials, temporarycrowns, and bridges. Thepatient receives anaesthetically andfunctionally comfortabledenture.	Similar with minorvariation - Both aretransparent, light-curedresins intended to sealacrylic dentures
Indications forUse	Coating Material is a light-cured, transparent resinsealant for acrylic denturebases that produces asmooth, glossy, andfunctionally comfortabledenture.	Photocuring lacquer forsealing dentures andtemporary crowns andbridges based on PMMA-resin.	Similar with minorvariation- both are acoating material fordentures. The predicate isalso intended for use intemporary crowns andbridges.
Area ofapplication	- Surface sealing ofdentures- Surface sealing ofdentures afterfinishing	- Surface sealing ofdentures- Surface sealing ofdentures afterfinishing- Surface sealing oftemporary crownsand bridges	Similar with minorvariation - both areintended for sealingdentures. They differ inthat the Palaseal is alsointended to be used as asurface sealant oftemporary crowns andbridges
Chemicalcomposition	Acrylic compounds,solvent, and a photoinitiator	Multifunctionalmethacrylate, methylmethacrylate, and a photoinitiator	Similar - The devices arecomposed of similaracrylic raw materials, havethe same intended useand technological

Table 5A - Comparison of Characteristics

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Manufacturer	Sun Medical Co., Ltd.	Heraeus Kulzer, Inc.	Significant Differences
Polymerization(Curing) Method	Cured by Ultraviolet (UV)radiation	Cured by Ultraviolet (UV)radiation	Same
Components	Two-Component System -Liquid A and Liquid B	One-component System -Denture Lacquer	Differ - The subject deviceis a two-part liquid systemthat requires the user tomix, and the predicate isone part liquid system.
Appearance	Smooth, high gloss surfacewith no evidence ofcracking or peeling afterbeing light-cured	Smooth, high gloss surfacewith no evidence ofcracking or peeling afterbeing light-cured	Same
Application	Applied with a brush or bydipping into a tub	Applied with a brush	Similar - Both may beapplied with a brush
Biocompatibility	ISO 10993-1, ISO 7405	ISO 10993-1, ISO 7405	Same

The subject and predicate devices are liguid formulations that contain acrylic compounds, solvent, and an initiator. All of the components of the Coating Material have similar to the predicate device. Coating Material requires the user to mix the two liquid components, while the predicate is a one-liquid product. The curing mechanism of the devices is polymerization of uncured acrylic monomers. This reaction is caused by a photo initiator system.

The Coating Material shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device. All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact device performance.

9. Non-Clinical Performance Data

Extensive testing has been performed on the subject denture base resin to demonstrate compliance with ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials. The following testing has been performed to support substantial equivalence:

Biocompatibility –The biological safety of the Coating Material was evaluated in accordance with ISO 7405:2008, ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a permanent exposure (C), surface-contacting device in contact with mucosal membranes. The Coating Material biocompatibility was tested for the following with the final results.

Cytotoxicity (MEM Elution Test) - The Coating Material was found to be noncytotoxic, and all test method acceptance criteria were met per ISO 10993-5.
Skin Sensitisation (Guinea Pig Maximization) - Coating Material is considered to cause no sensitization under the experimental conditions of this study per ISO 10993-10.

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Intracutaneous Reactivity - Coating Material caused no signs of irritation, met the requirements of the test and is classified as not irritant per ISO 10993-10.
. Subchronic Toxicity - Coating Material is considered to not cause significant systemic toxicity under the experimental conditions of this study per ISO 10993-11.
Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) - Coating Material extract is considered to be non-clastogenic under the experimental conditions of this study per ISO 10993-3.
. Genotoxicity Bacterial Reverse Mutation (AMES) Test - Coating Material was considered non-mutagenic (non-genotoxic and non-clastogenic) under the experimental conditions of this study per ISO 10993-3.

Performance Bench Testing - It is confirmed that the Coating Material conforms to the required specifications and is suitable for its intended use. Performance testing includes:

. Coating applicability
. The properties of the coated surface

Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form.

The Coating Material meets all the requirements for the overall design, performance, and biocompatibility, confirming that the output meets the design inputs and specifications. The Coating Material passed all testing stated above as shown by the acceptable results obtained.

The Coating Material complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years and there are no adverse reactions. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

The Coating Material has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. Coating Material, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.